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NCT04008537 Clinical Trial

Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

Cancer of Pancreas Clinical Trial

Official title:
A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04008537
Other study ID # 201908024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2019
Est. completion date March 8, 2022

Study information
Verified date April 2022
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date March 8, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation. - Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8). - At least 18 years of age - Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: - Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of a pregnancy test.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ring gantry kV-CBCT combined with linear accelerator
Each imaging session will be less than one hour, and is expected to take no more than 15 minutes.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of the device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions Completion of ART workflow in all enrolled participants (estimated to be 30 months)
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